Portable Oxygen Concentrator, Model Rs-00400

by Delphi Medical Systems 510(k)

Active United States

510(k) K073242

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK073242	Date3 Jan 2008Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K073242
FDA Product Code: CAW

Device Class: Class II
Regulation: 21 CFR Part 868.5440
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

Other devices from Delphi Medical Systems

Delphi Infusion Pump/ Delphi Administration Set Model Iv-01000/ Model Iv-02XXXX (Where X Is Any Number Between 0-9)

Class II